Azithromycin at birth: Single dose azithromycin shortly before birth - what is the impact on infection rates in high-risk mothers and babies? A randomised controlled trial

Phase 3

Recruiting

• Conditions: maternal post-natal infections; infant infections; Reproductive Health and Childbirth - Childbirth and postnatal care; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12624000247572
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-13
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 1548

Inclusion Criteria

1.Age greater than or equal to 16 years of age
2.Pregnant Northern Territory Aboriginal and / or Torres Strait Islander women
3.Pregnant non-Indigenous women who have an operative or preterm birth (27-36 weeks)
4.Birthing at Royal Darwin Hospital

Exclusion Criteria

1.Previously randomised
2.Azithromycin treatment within the last 7 days
3.Lack of access to a primary health provider in the NT
4.Allergy or hypersensitivity to azithromycin
5.Not able to provide informed consent
6.Gestation <26 weeks
7.Not available for assessment at 6 weeks
8.Women whose primary clinician intends to treat with azithromycin
9.A diagnosis of chorioamnionitis or intrapartum sepsis prior to randomisation with broad spectrum antibiotics planned for >48-72hrs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal infection requiring antibiotic intervention[Clinical file review from primary health and hospital care providers 6 weeks after birth];Infant infection requiring antibiotic intervention[Clinical file review from primary health and hospital care providers 6 weeks after birth]